BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25239466 · Received May 21, 2026

    Report

    Report Number
    3015488559-2026-00038
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 21, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. THE ISSUE WAS RESOLVED THROUGH POWERCYCLING THE SURGEON CONSOLE. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS ALLEGED THAT, WHEN CONNECTING THE SYSTEM FOR THE PROCEDURE, THERE WAS NO IMAGE FROM THE ENDOSCOPIC CAMERA. DURING TROUBLESHOOTING, THE USER TRIED TO RECONNECT THE CABLES AND REPLACE THE CAMERA HEAD. THE ISSUE WAS RESOLVED BY POWERCYCLING THE SURGEON CONSOLE. THE PROCEDURE WAS PERFORMED WITH THE USE OF VERSIUS SURGICAL SYSTEM, WITH NO FURTHER ISSUES. THE SURGEON CONSOLE HAS BEEN USED SINCE THIS EVENT WITH NO REPORTED ISSUES. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396728 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown